Official Title
Clinical-trial of COVID-19 Convalescent Plasma in Outpatients
Brief Summary

The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration. This study will adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.

Enrolling by invitation
COVID19

Biological: Convalescent Plasma
SARS-CoV-2 convalescent plasma with neutralizing SARS-CoV2 antibodies titers of ≥1:160 administered via intravenous (IV) infusion.
Convalescent Plasma

Biological: Saline
Saline with multivitamin administered via intravenous (IV) infusion..
Placebo

Eligibility Criteria

Inclusion Criteria: - One or more symptoms of COVID-19 illness and laboratory-confirmed SARS-CoV-2 infection - Has at least one study defined risk factor for severe COVID-19 illness - Clinical team deems stable for outpatient management without supplemental oxygen - CP available at the site at the time of enrollment - Duration of symptoms ≤ 7 days at ED presentation - Informed consent from subject

Exclusion Criteria: - Age less than 18 years - Prisoner or ward of the state - Presumed unable to complete follow-up assessments - Prior adverse reaction(s) from blood product transfusion - Receipt of any blood product within the past 120 days - Treating clinical team unwilling to administer 300 ml fluid - Enrollment in another interventional trial for COVID-19 illness

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Chandler Regional Medical Center
Chandler, Arizona, 85224

Valleywise Health Medical Center
Phoenix, Arizona, 85008

UCSD Health La Jolla
La Jolla, California, 92037

Loma Linda University Medical Center
Loma Linda, California, 92354

Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095

Cedars-Sinai Medical Center
Los Angeles, California, 90211

UC Davis Medical Center
Sacramento, California, 95817

Stanford University
Stanford, California, 94305

Harbor-UCLA Medical Center
Torrance, California, 90502

University of Colorado Hospital
Aurora, Colorado, 80045

UF Health Shands Hospital
Gainesville, Florida, 32608

Jackson Memorial Hospital
Miami, Florida, 33136

Grady Memorial Hospital
Atlanta, Georgia, 30303

Rush University Medical Center
Chicago, Illinois, 60612

University of Illinois Hospital
Chicago, Illinois, 60612

University of Chicago Medical Center
Chicago, Illinois, 60637

University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242

University of Louisville Hospital
Louisville, Kentucky, 40202

Maine Medical Center
Portland, Maine, 04102

Tufts Medical Center
Boston, Massachusetts, 02111

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215

Newton-Wellesley Hospital
Newton, Massachusetts, 02462

Baystate Medical Center
Springfield, Massachusetts, 01199

University of Michigan University Hospital
Ann Arbor, Michigan, 48109

Detroit Receiving Hospital
Detroit, Michigan, 48201

Harper University Hospital
Detroit, Michigan, 48201

Henry Ford Hospital
Detroit, Michigan, 48202

Sinai-Grace Hospital
Detroit, Michigan, 48235

Spectrum Health Hospitals Butterworth Hospital
Grand Rapids, Michigan, 49503

William Beaumont Hospital
Royal Oak, Michigan, 48073

William Beaumont Hospital-Troy
Troy, Michigan, 48085

HealthPartners Methodist Hospital
Saint Louis Park, Minnesota, 55426

Regions Hospital
Saint Paul, Minnesota, 55101

Cooper University Hospital
Camden, New Jersey, 08103

University of New Mexico Hospital
Albuquerque, New Mexico, 87106

SUNY Downstate Medical Center
Brooklyn, New York, 11203

Duke University Hospital
Durham, North Carolina, 27710

Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27103

University of Cincinnati Medical Center
Cincinnati, Ohio, 45219

OSU Wexner Medical Center
Columbus, Ohio, 43210

Mercy St. Vincent Medical Center
Toledo, Ohio, 43608

Oregon Health & Science University Hospital
Portland, Oregon, 97239

Geisinger Medical Center
Danville, Pennsylvania, 17822

Temple University Hospital
Philadelphia, Pennsylvania, 19140

Einstein Medical Center
Philadelphia, Pennsylvania, 19141

UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213

William P. Clements Jr. University Hospital
Dallas, Texas, 75235

Ben Taub General Hospital
Houston, Texas, 77030

Memorial Hermann Texas Medical Center
Houston, Texas, 77030

University of Utah Healthcare
Salt Lake City, Utah, 84132

Froedtert Hospital
Milwaukee, Wisconsin, 53226

Clifton W Callaway, MD, PhD
Principal Investigator
University of Pittsburgh

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Valerie Durkalski-Mauldin, PhD
Principal Investigator
Medical University of South Carolina

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Frederick Korley, MD, PhD
Principal Investigator
University of Michigan

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Sharon Yeatts, PhD
Principal Investigator
Medical University of South Carolina

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Robert Silbergleit, MD
Principal Investigator
University of Michigan

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William Barsan, MD
Principal Investigator
University of Michigan

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Kevin Schulman, MD
Study Director
Stanford University

Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network
University of Pittsburgh
Medical University of South Carolina
NCT Number